Maypharm
FDA issued a warning letter to Maypharm, a South Korea-based company, for selling unapproved and misbranded injectable botulinum toxin products (marketed as 'BOTULAX 200 units' and 'Botulax 200ui') to U.S. consumers via www.maypharm.net. The products lack FDA-approved drug applications under section 505 of the FD&C Act and are misbranded because their labeling fails to bear adequate directions for use as required for prescription drugs. FDA warned that unapproved injectable drugs pose serious risks including contamination, counterfeit ingredients, sepsis, and life-threatening adverse effects. The agency demanded corrective action within 15 working days and cautioned that failure to comply may result in seizure or injunction.
Flagged claims (1)
Botulax 200ui is successfully used for hyperhidrosis (increased sweating), blepharospasm, and correction of deep wrinkles.
Required actions (3)
FDA requests that www.maypharm.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
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